Medications & Supplements/Prescription Drugs

Hill Dermaceuticals, Inc.: DermOtic Oil Ear Drops Recalled for Potential Broken Glass in Dropper

Agency Publication Date: June 23, 2021

Summary

Hill Dermaceuticals, Inc. is recalling approximately 34,561 bottles and 773 sample bottles of DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops. This prescription medication is being recalled because there is a potential for broken glass fragments to be present inside the glass pipette of the dropper assembly. The recall affects 20 mL bottles distributed nationwide across the United States.

Risk

If broken glass is present in the dropper, it could be accidentally discharged into the ear canal during administration. This poses a risk of localized injury, such as cuts or irritation to the ear, or could lead to an ear infection.

What You Should Do

Check your medicine cabinet for 20 mL bottles of DermOtic Oil (fluocinolone acetonide oil) 0.01% with NDC 68791-103-20.
Verify the lot number and expiration date on the packaging. Affected lot numbers include: 19K036D (Exp. 05/21), 19L039E (Exp. 05/21), 20A001E (Exp. 07/21), 20A003D (Exp. 07/21), 20A003E (Exp. 07/21), 20C013G (Exp. 09/21), 20E025F (Exp. 12/21), 20E025G (Exp. 12/21), 20E025H (Exp. 12/21), 20H041D (Exp. 02/22), 20H041F (Exp. 02/22), 20J043E (Exp. 03/22), 20K050F (Exp. 04/22), 20L055E (Exp. 06/22), 21C015E (Exp. 09/22), and 21C018E (Exp. 09/22).
If your product matches the affected lot numbers, contact your healthcare provider or pharmacist for guidance before further use.
Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.
Contact Hill Dermaceuticals, Inc. for additional information regarding the return process and product concerns.
For general questions about food or drug safety, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Consult healthcare provider and return product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops (20 mL)

Model:

NDC 68791-103-20

Lot Numbers:

19K036D (Exp. 05/21)

19L039E (Exp. 05/21)

20A001E (Exp. 07/21)

20A003D (Exp. 07/21)

20A003E (Exp. 07/21)

20C013G (Exp. 09/21)

20E025F (Exp. 12/21)

20E025G (Exp. 12/21)

20E025H (Exp. 12/21)

20H041D (Exp. 02/22)

20H041F (Exp. 02/22)

20J043E (Exp. 03/22)

20K050F (Exp. 04/22)

20L055E (Exp. 06/22)

21C015E (Exp. 09/22)

21C018E (Exp. 09/22)

Date Ranges: Exp. 05/21, Exp. 07/21, Exp. 09/21, Exp. 12/21, Exp. 02/22, Exp. 03/22, Exp. 04/22, Exp. 06/22, Exp. 09/22

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87990

Status: Resolved

Manufacturer: Hill Dermaceuticals, Inc.

Sold By: Royal Pharmaceuticals; Pharmacies

Manufactured In: United States

Units Affected: 34,561 bottles for sale; 773 bottles for samples

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medicine cabinet for 20 mL bottles of DermOtic Oil (fluocinolone acetonide oil) 0.01% with NDC 68791-103-20.

Verify the lot number and expiration date on the packaging. Affected lot numbers include: 19K036D (Exp. 05/21), 19L039E (Exp. 05/21), 20A001E (Exp. 07/21), 20A003D (Exp. 07/21), 20A003E (Exp. 07/21), 20C013G (Exp. 09/21), 20E025F (Exp. 12/21), 20E025G (Exp. 12/21), 20E025H (Exp. 12/21), 20H041D (Exp. 02/22), 20H041F (Exp. 02/22), 20J043E (Exp. 03/22), 20K050F (Exp. 04/22), 20L055E (Exp. 06/22), 21C015E (Exp. 09/22), and 21C018E (Exp. 09/22).

If your product matches the affected lot numbers, contact your healthcare provider or pharmacist for guidance before further use.

Return any unused portions of the recalled medication to the pharmacy where you purchased it for a refund.

Contact Hill Dermaceuticals, Inc. for additional information regarding the return process and product concerns.

For general questions about food or drug safety, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops (20 mL)

Model:

NDC 68791-103-20

Lot Numbers:

19K036D (Exp. 05/21)

19L039E (Exp. 05/21)

20A001E (Exp. 07/21)

20A003D (Exp. 07/21)

20A003E (Exp. 07/21)

20C013G (Exp. 09/21)

20E025F (Exp. 12/21)

20E025G (Exp. 12/21)

20E025H (Exp. 12/21)

20H041D (Exp. 02/22)

20H041F (Exp. 02/22)

20J043E (Exp. 03/22)

20K050F (Exp. 04/22)

20L055E (Exp. 06/22)

21C015E (Exp. 09/22)

21C018E (Exp. 09/22)

Date Ranges: Exp. 05/21, Exp. 07/21, Exp. 09/21, Exp. 12/21, Exp. 02/22, Exp. 03/22, Exp. 04/22, Exp. 06/22, Exp. 09/22